|
Main
|
|
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
ISRCTN |
|
Last refreshed on:
|
10 August 2020 |
|
Main ID: |
ISRCTN89439892 |
|
Date of registration:
|
04/06/2018 |
|
Prospective Registration:
|
No |
|
Primary sponsor: |
|
|
Public title:
|
Evaluation of the effectiveness of an educational intervention in community pharmacists to improve pharmaceutical care in upper respiratory infections, including flu, colds, sore throat and sinusitis
|
|
Scientific title:
|
Evaluation of the effectiveness of an educational intervention in community pharmacists to improve pharmaceutical care in influenza, colds and upper respiratory infections: a cluster randomized controlled trial (IMATID) |
|
Date of first enrolment:
|
01/12/2016 |
|
Target sample size:
|
977 |
|
Recruitment status: |
Completed |
|
URL:
|
http://isrctn.com/ISRCTN89439892 |
|
Study type:
|
Interventional |
|
Study design:
|
Cluster randomized controlled trial (Other)
|
|
Phase:
|
Not Applicable
|
|
|
Countries of recruitment
|
|
Spain
| | | | | | | |
|
Contacts
|
|
Name:
|
|
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
|
|
|
Name:
|
Adolfo
Figueiras Guzmán |
|
Address:
|
Facultad de Medicina. Universidad de Santiago de Compostela
15782
Santiago de Compostela
Spain |
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
|
| |
|
Key inclusion & exclusion criteria
|
Inclusion criteria: All community pharmacists in two provinces in the northwest of Spain (A Coruña and Pontevedra).
Exclusion criteria: Does not meet inclusion criteria
Age minimum:
Age maximum:
Gender:
Both
|
|
Health Condition(s) or Problem(s) studied
|
Outpatient antibiotic consumption in patients with upper respiratory tract inffections
Infections and Infestations
Upper respiratory tract infection
|
|
Intervention(s)
|
All the pharmacies in the study area were grouped into 6 spatial clusters, depending on the different health areas. We assigned a number to each cluster. Using the Epidat program, a random 1:1 distribution was made.
The three randomly selected clusters received the intervention. It consisted of:
1. A formative session about antimicrobial resistance and the responsibility of community pharmacists. A health professional visited each pharmacy. These visitors explained some
current data of antibiotic resistance, the need to discover new antimicrobials, the association between antibiotic consumption and resistances development andthe role of pharmacist in health education, patient adherence to the antibiotic treatment, selection of appropriate over-the-counter medicines and identifying cases that should be referred to the doctor, thus avoiding dispensing antibiotics if they are not prescribed by a physician.
They also explained the opportunity to use new technologies, showing an application for mobile devices (eRes), designed for this study, as a decision support system based on the patient’s symptoms. Finally, they offered the possibility of updating their knowledge through an online course, also designed exclusively for this study. They gave a triptych as a reminder of the app and the online course. In addition, they gave informative materials for patients about the ineffectiveness of antibiotics against viral infections.
2. An online course about pharmaceutical care in upper respiratory tract infections. The course duration was 10 hours and consisted of 5 theoretical parts, one practical part and a final
evaluation. The course granted 1.8 credits of continuous
|
|
Primary Outcome(s)
|
|
Number of antibiotics dispensed without a medical prescription, 1 month before and 1 month after the intervention, by the simulated client method. The simulated patient presents with a respiratory infection, for which he requested an antibiotic without prescription. Four gradual levels of pressure are used to obtain the antibiotic.
|
|
Secondary Outcome(s)
|
1. Quality of pharmaceutical care was measured 1 month before and 1 month after the intervention using the simulated client method . It was evaluated by recording which other medications were offered, the reasons for not dispensing antibiotic and all the questions related to possible adverse reactions or contraindications.
2. Pressure level to obtain antibiotic was measured 1 month before and 1 month after the intervention using the simulated client method. Four gradual levels of demand were used to obtain the antibiotic. At the beginning the patient requests something for the symptoms and ends up requesting a specific antibiotic (amoxicillin)
|
|
Secondary ID(s)
|
|
PID15/00844
|
|
Source(s) of Monetary Support
|
|
Health Research Fund (Fondo de Investigación Sanitaria) from the Carlos III Health Institute (Instituto de Salud Carlos III)
|
|
Ethics review
|
Status:
Approval date:
Contact:
Galician Clinical Research Ethics Committee (Comité de Ética de investigación de Galicia), 20/10/2015
2015/597
|
|
Results
|
|
Results available:
|
|
|
Date Posted:
|
|
|
Date Completed:
|
31/12/2018 |
|
URL:
|
|
|
|